Pronumbra RT-4536-SA01

GUDID 00841439114728

Pronumbra Shoulder Adapter

MEDTEC, INC.

Indexed-immobilization patient positioning system
Primary Device ID00841439114728
NIH Device Record Key6f02f24d-63f3-4f10-81ae-2fb9521dc2a0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePronumbra
Version Model NumberRT-4536-SA01
Catalog NumberRT-4536-SA01
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439114728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXQTable, Radiographic, Stationary Top

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-22
Device Publish Date2025-09-12

On-Brand Devices [Pronumbra]

10841439114787Pronumbra Head, Neck & Shoulder Mask with Integrated Shim, 3.2mm Standard Perf
10841439114770Pronumbra Head Only Mask with Integrated Shim, 3.2mm Standard Perf Fibreplast
10841439114749Pronumbra Head, Neck & Shoulder Mask with Integrated Shim, 3.2mm Microperf Fibreplast
10841439114732Pronumbra Head Only Mask with Integrated Shim, 3.2mm Microperf Fibreplast
00841439115138Pronumbra 158cm kVue Package
00841439115121Pronumbra 163cm Overlay Package
00841439115008Pronumbra 163cm Overlay
00841439114995Pronumbra 160cm kVue
00841439114728Pronumbra Shoulder Adapter
00841439114711Pronumbra Neck Support, 65mm
00841439114704Pronumbra Neck Support, 50mm
00841439114698Pronumbra Neck Support, 40mm
00841439114681Pronumbra 130cm kVue
00841439114674Pronumbra Helping Hand, Right
00841439114650Pronumbra Helping Hand, Left

Trademark Results [Pronumbra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRONUMBRA
PRONUMBRA
78658298 3098227 Dead/Cancelled
Pronumbra LLC
2005-06-25
PRONUMBRA
PRONUMBRA
75810970 not registered Dead/Abandoned
Glaxo Group Limited
1999-09-29

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.